SK Bioscience Obtains EU-GMP Certification for COVID Vaccine Production Facility

Preparing for US cGMP Certification... Andong L House Expansion Project Plans Growth

SK Bioscience Andong L House (Photo by SK Bioscience)

SK Bioscience announced on the 17th that the COVID-19 vaccine production facilities, processes, and quality systems at its Andong Plant L House have obtained certification from the European Medicines Agency (EMA) for 'EU-GMP (Good Manufacturing Practice).' This is the first time a domestic vaccine manufacturing facility has received EU-GMP certification.

GMP is a certification system that applies strict management standards to all processes from raw material procurement to manufacturing, quality control, and shipment to ensure the production of high-quality medicines. In particular, EU-GMP is regarded as one of the highest standards globally, alongside the US cGMP.

SK Bioscience passed EMA's inspection process, including on-site audits and document reviews lasting over a month, and obtained final certification in March for contract manufacturing (CMO) of AstraZeneca's COVID-19 vaccine and on the 26th of last month for contract development and manufacturing (CDMO) of Novavax's COVID-19 vaccine candidate.

SK Bioscience plans to begin preparations for cGMP certification approved by the US Food and Drug Administration (FDA). Based on the capabilities demonstrated this time, the company will expand L House and grow its vaccine CMO and CDMO business with global companies, whose requests have been increasing following COVID-19 vaccine contract manufacturing. L House possesses advanced foundational technologies and production facilities for vaccine manufacturing, including ▲cell culture ▲bacterial culture ▲genetic recombination ▲protein conjugation, as well as research and development (R&D) personnel, enabling immediate large-scale production of new vaccines.

Jaeyong Ahn, CEO of SK Bioscience, said, "The pandemic is expected to cause explosive growth in global vaccine demand," adding, "We will accelerate business expansion based on the high-level technology recognized worldwide."